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Senior Systems Engineer

2 months ago

Marlborough, Massachusetts, United States Candela Medical Full time
Senior/Principal Systems Engineer Job Opportunity

Candela Medical is seeking a highly skilled Senior/Principal Systems Engineer to lead the development and implementation of aesthetic laser systems and accessories. This is a senior-level engineering position responsible for defining, architecting, and coordinating the implementation of engineering tasks across multiple product families.

Key Responsibilities:
  • Accountable for system architecture and supports software architecture definition.
  • Supports the creation of design concepts and initial feasibility.
  • Provides interface to industrial design companies and contract manufacturers for the development/PEO teams.
  • Primary interface into Engineering for projects.
  • Capable of rightsizing projects based on complexity.
  • Works closely with functional leads in their respective fields to develop detailed design specifications.
  • Is accountable for design inputs and outputs and works closely with the V&V project-leads to establish test and traceability strategies.
  • Knowledge of automation tools to support system product automation related to life testing.
  • Familiar with requirements management tools.
  • Is accountable for overseeing the integration and implementation of varying degrees of complexity across multiple product families.
  • Establishes test criteria and can execute testing for system level requirements.
  • Is a subject matter expert and participates in cross-product family reviews as a system architect.
  • Manages technical project schedules.
  • Manages the requirements engineering process.
  • Is accountable for the establishment and maintenance of system level engineering documentation.
  • Facilitates technical direction and brainstorming with remaining R&D team.
  • Debugs and characterizes defects.
  • Knowledgeable of compliance design controls and all regulatory requirements.
  • Ability to develop and document analytical models of system and subsystem behavior and interactions.
  • Works from schematics, diagrams, written and verbal descriptions, layouts, or defined plans to perform testing, checkout and trouble-shooting functions.
  • Performs operational test and fault isolation on systems and equipment.
  • Assists in determining methods or actions to remedy malfunctions.
  • Prepare for and participate in comprehensive design reviews.
  • Uses manufacturing, test, development, or diagnostic equipment.
Requirements:
  • BS or MS in electrical, mechanical, optical, or computer engineering or 15 years of equivalent experience.
  • Minimum of 15 plus years of related experience in systems engineering of complex medical devices.
  • Advanced knowledge of FDA, IEC and UL standards relating to medical devices.
  • Familiar with DFx and lean manufacturing concepts.
  • Define and develop system architectures and perform system analysis.
  • Define and develop system verification and validation test plans.
Skills and Abilities:
  • Excellent interpersonal, organizational as well as verbal and written communication skills.
  • Provide technical leadership on projects.
  • Strong technical and analytical abilities including DOE, and statistical analysis.
  • Strong problem-solving skills.
  • Good level familiarity with MS Project and/or Smartsheet.
  • Familiarity with requirements tools.
  • Familiarity with Labview, Test Complete, AutoIT or other automation tools.
  • Familiarity with statistical modeling packages.
  • Familiarity with high power laser products desirable.
  • Familiarity with optical modeling, fluid dynamics, heat transfer desirable.
  • Six sigma knowledge is an advantage.
  • Familiarity with DF'x and lean manufacturing concepts.
About Candela Medical:

Candela Medical is a leading manufacturer of aesthetic laser systems and accessories.